Tagged with AIFA

Global Over the past year, PharmaBoardroom has spoken to pharma executives the world over, collecting unique perspectives from all sides of the industry. Here are the ten most-read interviews of 2022 that range from conversations with one of Korea’s top CDMOs to the American generics association and the Italian regulatory agency,…

Italy Digitalisation has become a buzz word in in the global life sciences sector. In Italy, digital transformation has taken on special significance as one of the principal goals encompassed in the country’s National Recovery and Resilience Plan and a priority within its healthcare modernisation plans.   Novel solutions came out…

Italy The Italian system requires drug companies to go through approvals at a national level with the Italian Medicines Agency (AIFA), only to then confront the country’s 21 regional authorities who independently manage the budget for territorial pharmaceutical expenditure and evaluate regional access. According to many industry stakeholders, this lengthy process…

Italy Giorgio Palú, President of the Italian Medicines Agency (AIFA) helps us understand how the agency works, explains the criteria they use to evaluate innovative medicines and tells us about AIFA’s independent research program. AIFA has always favoured innovation and, in this context, has defined specific criteria with the aim of…

Italy In recent months, a profound transformation has been occurring right at the core of the Italian pharmaceutical industry as the most significant reforms to market access within two decades start to take shape. While Mario Draghi’s energetic government has been dominating the headlines primarily for other reasons – namely sweeping…

Italy In July 2020, Italy became the first country in the world to mandate pharma companies to disclose data surrounding public subsidies received for the development of new drugs. The decree came almost a year after an Italy-led World Health Assembly (WHA) resolution on transparency of markets for health products, comes…

Italy Below we present recent news from Italy’s biopharma industry, including the recent acquisition of Stemline Therapeutics by Menarini, research collaboration between Italy and China, labelling regulations, a new biotech sector report and new studies on antibodies against Covid-19.   Menarini gains presence in US oncology market with acquisition of Stemline…

Pharma Francesco di Marco, General Manager for Amgen Italy, shares his view on the state of the Italian pharmaceutical sector, the turnaround the company has made in the country, and what he sees as the keys to unlocking Italy’s potential for innovation over the next few years. Having worked for Amgen…

Pharma Dr. Ermano Buratti, General Manager for Astellas Pharma in Italy, discusses the company’s evolution as it enters its second decade, the importance of partnering with the government on reimbursement, the current state and need for change in the country’s healthcare system, and his efforts to put Astellas in a position…

Pharma Pasquale Frega, General Manager for Celgene Italy, discusses the company’s rapid growth and imminent entry into immunology, the business and regulatory environment for innovators in the country and the characteristics of the Italian market that make it especially promising to Celgene. Mr. Frega, to start off, Imnovid, Celgene’s newest oral treatment…

Pharma The Italian Medicines Agency, AIFA, sits at a crossroads. Its Director-General Prof. Luca Pani discusses the apparent contradiction in the agency’s mission at a time of constricting budgets and expensive medicines, how the agency’s role is evolving in response and in which ways the agency can collaborate with the industry.…

AIFA When you were appointed General Director of the Agenzia Italiana del Farmaco (AIFA) in 2007, the dedicated Investigation Commission highlighted the need for an in-depth reorganization of the Agency in order to create a more cohesive and transparent structure- which implied significant changes in the main six macro-areas and the…